510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K080048Substantially Equivalent

Msk Extreme Mr Scanner, Model Aa5000

Oni Medical Systems, Inc., Wilmington MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080048 is the FDA 510(k) clearance record for MSK EXTREME MR SCANNER, MODEL AA5000, a class II device, cleared for Oni Medical Systems, Inc. on under FDA product code LNH (System, Nuclear Magnetic Resonance Imaging). FDA records list one 510(k) clearance for Oni Medical Systems, Inc. As of , FDA records show 3 recalls naming K080048.

Clearance record

Decision date
Received
(29 days to decision)
Product code
LNH System, Nuclear Magnetic Resonance Imaging
Regulation
21 CFR 892.1000
Device class
Class II
Review panel
Radiology
Applicant
Oni Medical Systems, Inc. 301 Ballardvale St., Wilmington MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LNH

Trailing 12 months
26 clearances under product code LNH in the twelve months to October 2026, March 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code LNH, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20264
March 20266
April 20261
May 20261
June 20260
July 20262
August 20263
September 20263
October 20261